|- candidate number||22930|
|- NTR Number||NTR5484|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-okt-2015|
|- Secondary IDs||NL42977.018.15 |
|- Public Title||Cost-effectiveness of IVF for unexplained or mild male subfertility in women from 38 years up. A multi-centre randomized controlled trial.
|- Scientific Title||Cost-effectiveness of IVF for
unexplained or mild male subfertility in women from 38 years up.
A multi-centre randomized controlled trial|
|- hypothesis||Our hypothesis is that 8 months IVF results in 10% higher pregnancy rates leading to a live birth compared to 8 months expectant management.|
|- Healt Condition(s) or Problem(s) studied||IVF, Unexplained subfertility|
|- Inclusion criteria||- Age at least 38 and younger than 42 (women must be 38, 39, 40, or 41 at inclusion).|
- Had unprotected regular intercourse during at least 12 months without conception.
- Normal regular ovulatory cycle between 26 and 34 days as confirmed by either history,
basal temperature curve, ultrasound monitoring or serum progesterone
- Tubal patency of at least one tube as established with either hysterosalpingography,
contrastsonography, or diagnostic laparoscopy, or a confirmed earlier intra-uterine pregnancy (miscarriage or ongoing) not through IVF.
- Partners with normal or mildly impaired semen quality (TMSC ¡İ 3 million).
|- Exclusion criteria||- Age <38 or >42 at the time of inclusion|
- Irregular cycle, defined as < 25 days or >34 days.
- Double sided tubal occlusion
- Poor semen quality (TMSC <3 million)
- Couples undergoing IVF combined with Pre-implantation Genetic Diagnosis
- Couples undergoing ICSI combined with TESE (testiculair spermextraction)
- Couples undergoing IVF or ICSI with donor sperm
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2015|
|- planned closingdate||1-jan-2017|
|- Target number of participants||440|
|- Interventions||IVF treatment versus expectant management|
|- Primary outcome||The primary outcome is ongoing pregnancy resulting in live birth, conceived within a period of 8 months after randomisation|
|- Secondary outcome||Secondary outcomes are clinical pregnancy, multiple pregnancy, miscarriage, pregnancy complications, premature birth, couples¡¯ preferences, quality of life and costs. In a cost-effectiveness analysis, we will calculate incremental costs per ongoing pregnancy conceived within a time horizon of 8 months after randomisation comparing IVF to expectant management. |
|- Timepoints||a time horizon of 8 months after randomisation|
|- Trial web site||http://www.studies-obsgyn.nl/ivf38|
|- CONTACT FOR PUBLIC QUERIES||dr. M.H. Mochtar|
|- CONTACT for SCIENTIFIC QUERIES||MD. M.H. Mochtar|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||1-okt-2015 - 5-jan-2016|